The primary objective of this study is to prospectively investigate hemostatic activity following transcatheter left atrial appendage occlusion (LAAO).
This is a prospective cohort study of patients undergoing transcatheter LAAO at Aarhus University Hospital. Hemostatic consequences following device implantation will be evaluated using blood samples collected pre- and post-procedurally, and serially during three months follow-up in 135 LAAO patients. Platelet function and characteristics, overall activation of the extrinsic coagulation pathway and the intrinsic contact activation pathway, as well as endothelial response to implantation, will be assessed through a wide range of biochemical analyses. Patients will serve as their own controls, with a final control blood sample collected at three-months follow-up.
Study Type
OBSERVATIONAL
Enrollment
135
Interventional left atrial appendage occlusion with the Amulet or Watchman device
Aarhus University Hospital
Aarhus N, Central Denmark, Denmark
Change in coagulation activity
Coagulation activity as measured by prothrombin fragment 1+2
Time frame: 7 days, 14 days, 90 days
Change in platelet activity
Incl. platelet count, turnover, and aggregation
Time frame: 7 days, 14 days, 90 days
Additional measures of changes in coagulation and contact activation
Incl. thrombin generation, fibrinogen, d-dimer and coagulation factors
Time frame: 7 days, 14 days, 90 days
Change in endothelial activation and response
Incl. changes in soluble thrombomodulin, syndecan-1, selectin and von Willebrand factor
Time frame: 7 days, 14 days, 90 days
Non-procedural bleeding events
As defined by the Bleeding Academic Research Consortium
Time frame: 7 days, 14 days, 90 days
Radiographical evidence of device endothelization
On CT indicated by no contrast patency distal to the LAAO device.
Time frame: 7 days, 14 days, 90 days
Radiographically confirmed device-related thrombosis
Defined as high grade HAT on follow-up cardiac CT or TEE
Time frame: 7 days, 14 days, 90 days
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